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2 주 전
eShape Lifesciences® Announces EU MDR Certification for Entire European and United Kingdom Product Portfolio
IRVINE, Calif., June 03, 2025 (GLOBE NEWSWIRE) -- ReShape Lifesciences® (Nasdaq: RSLS), the premier physician-led weight loss and metabolic health solutions company, today announced that its Quality Management System (QMS) and entire commercial portfolio of medical devices sold in Europe and in the United Kingdom (UK) have been certified under the European Union (EU) Medical Device Regulation (MDR) (EU) 2017/745 and UK Conformity Assessment (UKCA), respectively.
The EU MDR, which replaced the Medical Device Directive (MDD) in May 2021, sets significantly more stringent requirements for clinical evaluation, post-market surveillance, and device traceability. Its goal is to improve patient safety, transparency, and product quality across all 30 countries within the European Economic Area (EEA). The UKCA has replaced the CE mark for certain goods placed on the market in Great Britain (England, Scotland, and Wales). It ensures that products meet the UK's regulatory requirements for safety, health, and environmental protection.
“Achieving MDR and UKCA certification well in advance of the December 31, 2027 regulatory deadline is a significant milestone that firmly establishes ReShape Lifesciences among a select group of medical device manufacturers capable of meeting the European Union’s rigorous new standards,” stated Paul F. Hickey, President and Chief Executive Officer of ReShape Lifesciences. “We have invested in the infrastructure necessary not only to comply with the MDR’s demanding framework, but also to support ongoing innovation and maintain seamless access to all 30 countries within the EEA. We are proud to join the relatively small number of companies that have successfully navigated this rigorous process. As a result, ReShape Lifesciences is uniquely positioned to expand its product pipeline, knowing that the systems and infrastructure supporting its QMS align with the EU’s and UK’s highest standards. This certification not only secures our continued presence in the European market, but also reinforces our mission to deliver safe, effective, and innovative solutions to patients living with obesity worldwide.”
“Securing MDR and UKCA certification for our products and our QMS is a clear validation of our regulatory and quality systems,” said Dov Gal, Vice President of Regulatory, Quality, and Clinical Affairs at ReShape Lifesciences. “As of late 2023 and early 2024, many legacy devices that were previously approved under the older MDD framework were still awaiting MDR and UKCA certification. With only a small percentage of applications resulting in approved certificates at that time, the risk of device shortages across the EU market became increasingly apparent. ReShape’s early compliance ensures uninterrupted availability of our devices in Europe and demonstrates our commitment to meeting the highest standards of safety and performance under the new regulatory landscape.”
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2 월 전
ReShape Lifesciences® Presents Pre-clinical Data on Its Proprietary Diabetes Neuromodulation Device at the 12th Annual Minnesota Neuromodulation Symposium
Vagal Neuromodulation Offers a Novel Approach to Treating Diabetes and Hypoglycemia
Device Demonstrates the Ability to Modulate Glucose Levels Without Cardiac Side Effects, Overcoming a Key Limitation Of Conventional Vagal Stimulation Techniques
IRVINE, Calif., May 02, 2025 (GLOBE NEWSWIRE) -- ReShape Lifesciences® (Nasdaq: RSLS), the premier physician-led weight loss and metabolic health solutions company, today announced it will present pre-clinical data on its proprietary Diabetes Neuromodulation device in a poster presentation at the 12th Annual Minnesota Neuromodulation Symposium, being held in Minneapolis.
Poster Presentation Details:
Poster Title: Stimulation of the Posterior Sub-Diaphragmatic Vagal Trunk Reverses Insulin-Induced Severe Hypoglycemia in a Swine Model of Type 1 Diabetes Mellitus
Poster Number: 3308
Author: Jonathan J. Waataja, Ph.D., Director of Research at ReShape Lifesciences®
Session: Session B
Date: May 2, 2025
Time: 10:45 am -1:00 pm CT
“Hypoglycemia remains a significant barrier to effective diabetes management, contributing to severe health risks and reduced quality of life,” stated Dr. Waataja. “Our Diabetes Neuromodulation technology utilizes Hypoglycemia Vagus Nerve Stimulation (HVNS), targeting stimulation of the sub-diaphragmatic posterior vagus nerve (PVN) to rapidly increase blood glucose (BG) during hypoglycemic episodes. The ability to avoid cardiac side effects while effectively mitigating BG is critical for clinical viability. Unlike conventional vagal stimulation techniques, our targeted HVNS approach alters glucose levels without impacting heart rate, blood pressure or respiration, overcoming a key limitation of conventional vagal stimulation techniques. Also, sub-diaphragmatic stimulation does not affect speech, which is an obstacle to increasing desired therapeutic levels with conventional vagal stimulation. The pre-clinical data presented today paves the way for the continued development of our proprietary technology aimed at reducing dependence on injections and wearable glucose monitors, with the potential to dramatically improve quality of life for people with Type 1 or Type 2 diabetes.”
Designed to evaluate HVNS efficacy and off-target systemic effects in a Type 1 diabetic swine model, laparoscopic placement of an electrode on the PVN successfully increased blood glucose levels and glucagon secretion without impacting cardiac output. Following insulin-induced hypoglycemia (blood glucose
INV4
2 월 전
Another after market party! +90% 🥳 💹
ReShape Lifesciences® Partners with Motion Informatics to Bring AI-Driven Neurorehabilitation Technology to the U.S. Market
April 09, 2025
ReShape Lifesciences® (Nasdaq: RSLS), the premier physician-led weight loss and metabolic health solutions company, today announced that it has signed an agreement with Haifa, Israel-based Motion Informatics to exclusively import and distribute their next-generation neuromuscular rehabilitation devices in the U.S. The flagship product, the Stimel-03, was showcased at the American Occupational Therapy Association 2025 Annual Conference and Expo, held April 3-5, 2025, in Philadelphia, PA.
“The signing of this agreement with Motion Informatics marks a significant milestone for ReShape as we expand and diversify into rehabilitation technology,” stated Paul F. Hickey, President and Chief Executive Officer of ReShape Lifesciences. “This partnership presents a unique opportunity to bring cutting-edge, neurorehabilitation solutions to the U.S. market. We are particularly excited to distribute the FDA cleared and commercially available Stimel-03, a breakthrough system that integrates Functional Electrical Stimulation (FES), Neuromuscular Electrical Stimulation (NMES), and real-time electromyographic (EMG) biofeedback into a single, patient-responsive platform—redefining rehabilitation for patients recovering from stroke, injury, or surgery. Motion Informatics’ innovative devices align well with our commitment to improving patient outcomes, complementing our core competencies including commercialization of differentiated products including our Lap-Band® 2.0 FLEX, designed to improve patients’ quality of life while driving meaningful clinical and commercial impact.”
“This partnership accelerates Motion Informatics’ U.S. market strategy by combining ReShape Lifesciences’ commercial reach with our differentiated rehabilitation technologies,” added Gary Sagiv, Chief Executive Officer of Motion Informatics. “Our FDA-cleared Stimel-03 is changing clinical care using real-time EMG biofeedback and personalized electrical stimulation, making it easy to use in both clinic and home settings. Spatial StimelMD (SSMD), our next-generation platform and the first closed-loop neuromotor intelligence system combining AI-personalized neuromodulation, real-time EMG biofeedback, and augmented reality into one adaptive rehabilitation process. The SSMD reads a patient’s intent and generates cadenced stimulation to match, adapting in real-time based on performance, fatigue, and recovery—delivering precise care in clinics, at home, and through telemedicine. Together, these technologies position Motion Informatics and ReShape Lifesciences at the forefront of the neuromuscular rehabilitation market—delivering differentiated capabilities, validated outcomes, and a scalable path to global expansion. We are confident that ReShape is the ideal partner to distribute our products and expand their impact across the U.S.”
About Motion Informatics
Motion Informatics is pioneering next-generation neuromuscular rehabilitation by integrating AI-driven neuroinformatics, augmented reality (AR), and digital health into a seamless, adaptive therapeutic platform. The Company’s Spatial StimelMD (SSMD) leverages personalized real-time electrophysiological data, biofeedback-driven neuromodulation, and AI-optimized intervention protocols to dynamically personalize therapy, enhancing neuroplasticity, motor re-education, and functional recovery in conditions such as stroke, spinal cord injuries, and neuromuscular disorders. By fusing biomechanical modeling, predictive analytics, and remote neurorehabilitation, the Company is redefining precision rehabilitation, creating a highly scalable, intelligent, and data-driven ecosystem that bridges clinical and home-based care. This paradigmshift will establish AI-powered, fully autonomous, and continuously adaptive neuromuscular therapy, fundamentally transforming the future of digital healthcare.
About ReShape Lifesciences®
ReShape Lifesciences® is America’s premier weight loss and metabolic health-solutions company, offering an integrated portfolio of proven products and services that manage and treat obesity and metabolic disease. The FDA-approved Lap-Band® System provides minimally invasive, long-term treatment of obesity and is an alternative to more invasive surgical stapling procedures such as the gastric bypass or sleeve gastrectomy. The investigational Diabetes Bloc-Stim Neuromodulation™ (DBSN™) system utilizes a proprietary vagus nerve block and stimulation technology platform for the treatment of type 2 diabetes and metabolic disorders. The Obalon® balloon technology is a non-surgical, swallowable, gas-filled intra-gastric balloon that is designed to provide long-lasting weight loss. For more information, please visit www.reshapelifesciences.com.
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